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Case Detail


In re FDA Device Recall Reporting Requirements
On May 23, 2013, WLF filed formal comments with the Food and Drug Administration (FDA), urging it to withdraw its Draft Guidance regarding medical device manufacturers’ responsibilities to file reports with FDA when they make safety-related changes to their products. WLF argued that the Draft Guidance conflicts with formal regulations issued by FDA in 1997, which made clear that reporting requirements kick in if and only if the prior version of the medical device raised serious safety issues. The Draft Guidance would dramatically expand the reporting requirements, by requiring a manufacturer to report all product enhancements that are initiated to reduce a risk to health posed by the device – even if the prior version of the device was perfectly safe. WLF charged that the Administrative Procedure Act (APA) bars federal agencies from (as here) attempting to amend an existing formal regulation without going through the APA’s formal notice-and-comment procedures.
Case Status:
Awaiting FDA action.
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